Regeneron’s pre-filled syringe for eye injection finally approved by FDA 20-Aug-2019 By Maggie Lynch Regeneron receives FDA approval on its Eylea pre-filled syringe injection after a CRL last year requesting additional data.
EU rules Avastin can be reimbursed for off-label use 30-Nov-2018 By Maggie Lynch The European Court of Justice has determined that Roche’s Avastin may be reimbursed for ARMD – despite Novartis and Bayer’s challenge.
West: Amgen mAb approval helps validate drug delivery tech 01-Aug-2016 By Dan Stanton Regulatory approvals are driving interest in West's Smartdose and Crystal Zenith delivery technologies, the firm says ahead of the launch of a monthly-dose version of Amgen's Repatha.